Job Title: Associate Director, Medical Writing
About the role: We are seeking an experienced Associate Director of Medical Writing to lead our medical writing activities and serve as an expert Medical Writer. You will be responsible for planning, developing, and writing clinical and regulatory documents to support medical and regulatory activities across our portfolio.
About the company: Our client is a growing biotechnology company at the forefront of Oncology innovation within Radiopharmaceuticals. We offer an attractive salary and package, and a hybrid/remote working arrangement.
Key responsibilities: As Associate Director, Medical Writing, you will
* Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.
* Confidently develop documents such as clinical trial outlines, clinical trial protocols/amendments, Clinical/Non-clinical 2.4, 2.5, 2.6, 2.7 CTD modules, investigators brochures, PIPs, DSURs, CSRs, Health Authority briefing books, and clinical submission documents.
* Serve as a document or process subject matter expert, leading cross-functional and cross-department process improvement initiatives.
* Solidify medical writing activities across all stages of drug development.
Requirements: At minimum, you will need a degree in life sciences and at least 10 years of medical or regulatory/clinical writing experience, in the pharmaceutical industry. Oncology experience is highly preferred.
About our client: As a leading biotechnology company, we are dedicated to innovating in Oncology and Radiopharmaceuticals. Our company culture values collaboration, innovation, and expertise.